San Diego Biotech

FDA panel overwhelmingly backs Vivus’ diet drug

Ryan McBride — Wed, 22 Feb 2012 21:57:41 +0000

Who said this panel vote would be close? Non-agency experts gave strong support to Vivus' ($VVUS) quest to gain FDA approval for its diet pill Qnexa, voting 20-2 this afternoon to support the drug getting a green light to hit the U.S. market, TheStreet reported.

The Endocrinologic and Metabolic Drugs Advisory Committee vote comes ahead of the FDA's decision, which is expected by April 17, on whether to stamp an approval on the Mountain View, CA-based developer's drug. If approved, Qnexa would be the first new diet pill to garner FDA approval in more than a decade. The agency, as many know, is not required to follow such panel's recommendations, but it often does.

Industry watchers have been largely split on Vivus' chances of gaining a nod for its latest approval bid, as U.S. regulators have taken a tough stance on the safety of diet drugs because of their side effects. The FDA, which shot down Vivus' first bid for Qnexa's approval in 2010, released its staff review of the company's latest application, noting previous concerns about the cardiovascular side effects of the drug, as well as the risk of birth defects in the offspring of mothers on the treatment.

During today's committee session, non-agency experts and company officials discussed having a risk evaluation and mitigation strategy for Qnexa to limit any ill effects of the drug on patients. Prior to today's panel vote, analysts had speculated from the tenor of the FDA's briefing documents that the agency might delay approval of Qnexa to seek additional safety information.

Vivus has been among three drug developers including Arena Pharmaceuticals ($ARNA) and Orexigen ($OREX) that have been racing to gain approval for new weight-loss drugs. The panel's favorable vote on Qnexa appears to have spurred a jump in the stock prices of Arena (6%) and Orexigen (14%) in after-hours trading.

There's no question that a stout market awaits new weight-loss drugs. Two out of three Americans are either overweight or obese, and drug developers have been vying to fill a gap in the market that isn't addressed with existing interventions such as dieting, exercise and bariatric surgery. The CDC has put the annual cost of obesity--which can lead to diabetes, heart attacks and other health problems--at $147 billion in the U.S. alone.

- here's The Street's live blog
- get more from Reuters
- and here's more from the Los Angeles Times

Dr. Jill Biden Kicks-Off Community College to Career Bus Tour

biotechnow@bio.org (Biotechnology Industry Organization) — Wed, 22 Feb 2012 19:17:47 +0000

Dr. Jill Biden and U.S. Labor Secretary Hilda Solis will embark on a five-state “Community College to Career” bus tour to highlight innovative industry partnerships this week. The tour will begin on February 22 with a visit at Columbus State Community College before continuing to DG Medical.

Dr. Jill Biden, wife of Vice President Joe Biden

At DG Medical, Dr. Biden and Secretary Solis will join BioOhio and Sinclair Community College officials to see first-hand the impact of a U.S. Department of Labor grant-funded biomedical training program led by BioOhio.

Launched in 2010, the three-year Ohio Bioworkforce Training Partnership aims to deliver training to 660 displaced or underemployed workers in declining industries for careers in Ohio’s growing bioscience industry. In addition, 40 incumbent workers will receive more advanced training to move into higher level jobs. Several DG Medical employees have completed training at Sinclair Community College, one of the program’s six college partners.

Secretary of Labor Hilda L. Solis, 25th United States Secretary of Labor

Last week, President Obama announced a new $8 billion Community College to Career Fund co-administered by the Department of Labor and Department of Education to forge new partnerships between community colleges and businesses to train two million workers with skills that will lead directly to jobs.

Dr. Biden, a community college instructor for 18 years, and Secretary Solis, who began her career in public service as a community college trustee, will highlight the unique role community colleges can play in creating a flexible, highly-skilled 21st-century workforce to help businesses meet the specific emerging needs in their regions.

Special thanks to my friends at BioOhio for the heads-up and press release on this public awareness initative.

Eisai co-developing cancer drug fueled by bacteria; U.S. trials launch soon

Mark Hollmer — Wed, 22 Feb 2012 16:59:21 +0000

Tokyo's Anaeropharma Science is launching U.S. clinical trials as early as March for a new stomach cancer drug fueled by bacteria. The biotech is partnering with Japanese drug giant Eisai to bring the treatment to market, according to the Daily Yomiuri. Testing will involve 60 patients over 3 ½ years. Anaeropharma loads the drug with bifidobacteria, which helps the drug both reach and build up within its tumor target because it is drawn to environments lacking oxygen, just like solid tumors. An anticancer agent taken by mouth then selectively targets those tumors after reacting to the drug, according to the article. Story

Venture backer makes $7M bet on cardio drug tech that could rival stents

Ryan McBride — Wed, 22 Feb 2012 16:53:19 +0000

With drug delivery tech from a children's hospital in Philadelphia, Vascular Magnetics has pocketed a $7 million Series A round from lone investor Devon Park Bioventures. And the startup has ambitious plans to advance magnetic drug-loaded particles for the huge market to treat peripheral artery disease--offering a potential alternative to a range of existing interventions against the disease that affects some 10 million Americans, according to the company.

The startup's tech is based on the published work of Dr. Robert Levy at The Children's Hospital of Philadelphia. The company proposes to develop Levy's magnetic drug-loaded particles to deliver treatments directly to diseased tissue with the aid of a magnetic catheter system and an external device to create a magnetic field, making the proposed product a true drug-device combo. The financing is expected to be enough to propel the company through preclinical development and an initial human trial, according to the company's COO and co-founder Richard Woodward.

"Current treatments for PAD such as angioplasty, grafts and stents, including drug-eluting stents, are not durable, with arterial re-obstruction (restenosis) occurring frequently," company Chairman Georges Gemayel said in a statement. "Vascular Magnetics' innovative approach to enhance local drug delivery has great potential to transform PAD treatment by delivering anti-restenotic drugs specifically to diseased artery sites at higher concentrations than are possible with drug-eluting stents."

Woodward stated that the startup aims to launch its maiden trial in 2014.

- here's the release

Venture backer makes $7M bet on cardio drug tech that could rival stents

Ryan McBride — Wed, 22 Feb 2012 16:53:19 +0000

Woodward stated that the startup aims to launch its maiden trial in 2014.

- here's the release

Collegium Pharma scores $22M round for abuse-preventing painkiller in Phase III

Ryan McBride — Wed, 22 Feb 2012 16:08:45 +0000

Venture backers have rallied behind Collegium Pharmaceutical to continue a late-stage trial for its extended-release version of oxycodone. The investors--led by Longitude Capital and Skyline Ventures, and including Frazier Healthcare Ventures and Boston Millennia Partners--are betting $22.5 million in the developer's Series B round.

With traditional oxycodone offering a recipe for abuse, Collegium has a proprietary formulation of the popular pain drug dubbed COL-003 that aims to thwart the type of tampering such as crushing and snorting the drug that addicts employ. A late-stage trial for the company's lead drug is under way, and the fresh round of capital is expected to be enough to fund the developer through potential FDA approval of the treatment, according to the company's release. Collegium plans to file an application for U.S. approval of COL-003 in 2013.

"We believe that with the ongoing national epidemic of prescription drug abuse there remains a significant unmet clinical need for tamper-resistant formulations that can mitigate abuse/misuse of opioid products," Collegium CEO Michael Heffernan said in the release.

A challenge for Collegium, naturally, will be setting itself apart from the pack of drugmakers in the pain field. Competitors are at various stages of advancing their own recipes for stymying abuse of pain pills. For instance, Purdue Pharma won FDA approval for a new formulation of OxyContin (oxycodone) in 2010 that offers controlled release of the drug and measures to prevent tampering.

- here's Collegium's release

Collegium Pharma scores $22M round for abuse-preventing painkiller in Phase III

Ryan McBride — Wed, 22 Feb 2012 16:08:45 +0000

- here's Collegium's release

Biotech VCs wait for big checks from string of buyout deals

Ryan McBride — Wed, 22 Feb 2012 15:16:46 +0000

Holding most of the cards in M&A deals, drugmakers have increasingly scored biotech buyouts with much of the payments to startup investors delayed unit certain goals are met. The danger of the deals is that investors face slim odds of raking in all the milestone payments tied to the buyouts, as many of the programs that must succeed in order for payments to be made often fail. One biotech backer from Atlas Venture has taken a stab at calculating the actual earnings from a sample of such deals.

Plucking numbers from a variety of public sources and data from individuals, Atlas Partner Bruce Booth writes that 24% of milestone payments were actually received from buyout deals involving drug developers from January 2005 to December 2009. Those payments amounted to $1.7 billion to biotech investors, and some of the milestone money remains on the table as related programs advance, but the figure illustrates how the big "potential" buyout figures seldom become real dollars. His research shows that 40% of the milestones from those 35 deals could be collected, yet 37% of the payments are out the window because programs to which they are tied have been tossed.

The so-called "biobucks" tied to these deals are often overlooked in the press after the deals are closed, but biotech investors obviously pay close attention to how much money they will actually receive from M&A events. With VCs dropping from the ranks of potential sources of capital, hope that the "biobuck"-laden deals bear fruit for these investors and entice them to make more bets on biotech startups. With IPOs hard to come by for small drug developers, drugmakers might offer venture backers their best shot at returns on their biotech investments.

Booth and his firm are among the ranks of VCs still waiting for big checks from drugmakers that have bought their portfolio companies. In the past two months, the VC firm has seen two of its drug developers--Stromedix and Avila--scooped up in deals that provided only part of the total payouts upfront. For instance, Biogen Idec ($BIIB) snapped up Stromedix for $75 million upfront and the lion's share of the potential payout, $487.5 million, tied to the success of the startup's fibrosis programs. Booth is asking his counterparts in the industry to help him compile a more complete picture of how much in the way of biobucks they are actually pocketing.

- get more from Booth's blog

Genomics revolution ignites new M&A talk, showstoppers

Ryan McBride — Wed, 22 Feb 2012 14:30:41 +0000

Roche's $5.7 billion hostile bid to scoop up DNA sequencing machine maker Illumina ($ILMN) has triggered talk of further merger targets in the promising genomics arena. And the race to invent faster and cheaper ways of decoding the genome has pushed small companies to the cutting edge of the field, giving industry leaders such as Illumina and Life Technologies ($LIFE) a run for their money.

While Swiss drug giant Roche continues its advance to gobble up a resistant Illumina, analysts have noted that rival Life Technologies could generate interest from other companies wanting a foothold in the blossoming market for DNA sequencers, Bloomberg reports. Genomics touches drug development, diagnostics and basic research. Other potential targets could be cancer test maker Genomic Health and Affymetrics, a maker of gene-analysis products, JMP Securities said, as quoted by Bloomberg.

"Roche's hostile bid for Illumina sparked a lot of interest in the genetic sequencing space," Alex Morozov, a Morningstar analyst, told the news service. Buyers could "look to supplement their internal R&D with external candidates, especially if they see something that could potentially be promising."

Both Life Technologies and Illumina announced last month their latest sequencers promise to push the cost of decoding a whole genome to the prized price tag of $1,000, making the technology more practical for screening patients' DNA for genetic clues about the best treatments. Drugmakers have seized the fruits of the technology as sequencers uncover new genetic targets for personalized drugs against cancer and genetic diseases.

Roche, which is also a leading diagnostics company, has stood alone among the Big Pharma groups making bids for sequencing companies. Sanofi CEO Chris Viehbacher has already said his company would prefer to stick to partnerships to access such platform technologies. Rather, the large potential buyers include companies with diversified healthcare businesses such as General Electric ($GE) and Siemens, Bloomberg reported. Experts have pointed out the speed at which the genomics field is changing, potentially making the standout products of today obsolete in a short period of time.

The field was reminded of this rapid change last week at a genomics meeting in Florida, during which Oxford Nanopore Technologies technology chief Clive Brown unveiled a sequencer that will cost just $900 and fit neatly in a device that is the size of a computer thumb drive, Xconomy reported.

- check out Bloomberg's article
 - see Xconomy's report

Related Article:
Roche looks to snatch up Illumina for $5.7B

Lee Hood startup grabs $10M to advance class of protein-capture agents

Ryan McBride — Wed, 22 Feb 2012 13:23:02 +0000

Biotech visionary Lee Hood's startup Integrated Diagnostics has reeled in fresh capital to roll into commercial mode with its novel protein-catalyzed capture (PCC) agents. The molecules are in development as diagnostic and therapeutic agents, with the bold goal of being able to simultaneously detect myriad markers in a patient's blood to detect diseases such as lung cancer and Alzheimer's.

The Seattle-based company's $10 million tranche announced today wraps up its $30 million Series A round first revealed in 2009. With the company initially seeking to bring to market blood-based diagnostics, CEO Al Luderer told Xconomy that he expects the company's first commercial product to be available in a little more than a year. To bolster its commercial aspirations, the company has named Jim Garner its chief business officer and Guy Seaton as its CFO.

"As InDi moves swiftly towards commercialization, the third tranche demonstrates the progress we've made in validating our in vitro diagnostic programs as well as our novel class of diagnostic and therapeutic molecules," Luderer said in a statement. "In two short years, we have met our two main objectives: define a new in vitro proteomic diagnostic platform capable of answering previously unanswerable diagnostic questions and; demonstrate the feasibility of a new in vivo molecular diagnostic and therapeutic molecular class: PCCs."

The company's platform is based on work from Hood's lab at The Institute for Systems Biology and it has licensed tech from Caltech as well. Its lineup of venture backers includes InterWest Partners, The Wellcome Trust and the Grand Duchy of Luxembourg.

- here's the release 
- get more in Xconomy's article